Multi- array monophasic potential medical device

ABSTRACT

A medical device including a catheter having a shaft with a distal portion; a first plurality of substantially hemispherical electrodes coupled to the distal portion; a second plurality of substantially hemispherical electrodes coupled to the shaft proximal of the first plurality, where the second plurality of electrodes are oriented substantially orthogonal to the first plurality of electrodes; and an additional electrode coupled to the shaft. A console may have a processor in electrical communication with the first and second plurality of electrodes and the reference electrode, the processor programmed to obtaining a monophasic action potential recording from at least one of the first and second plurality of electrodes.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a divisional of and claims priority to patentapplication Ser. No. 13/044,698, filed Mar. 10, 2011, entitledMULTI-ARRAY MONOPHASIC ACTION POTENTIAL MEDICAL DEVICE, the entirety ofwhich is incorporated herein by reference.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

n/a

FIELD OF THE INVENTION

The present invention relates to medical systems and methods for cardiactissue diagnosis and treatment.

BACKGROUND OF THE INVENTION

Medical procedures are available for treatment of a variety ofcardiovascular maladies, such as cardiac arrhythmias, atrialfibrillation, and other irregularities in the transmission of electricalimpulses through the heart. As an alternative to open-heart surgery,many medical procedures are performed using minimally invasive surgicaltechniques, where one or more slender implements are inserted throughone or more small incisions into a patient's body. Such procedures mayinvolve the use of catheters or probes having multiple sensors,electrodes, or other measurement and treatment components to treat thediseased area of the heart, vasculature, or other tissue.Minimally-invasive devices are desirable for various medical andsurgical applications because they allow for shorter patient recoverytimes compared to surgery, and for precise treatment of localizeddiscrete tissues that are otherwise difficult to access. For example,catheters may be easily inserted and navigated through the blood vesselsand arteries, allowing non-invasive access to areas of the body withrelatively little trauma, while other minimally-invasive probes orinstruments may be inserted into small openings and directed throughtargeted anatomy without significant impact or disruption to surroundingtissue.

One such example of a minimally invasive therapy involves the treatmentof cardiac arrhythmias or irregular heartbeats in which physiciansemploy specialized cardiac assessment and treatment devices, such as amapping and/or ablation catheter, to gain access to interior regions ofa patient's body. Such devices may include tip electrodes or otherablating elements to create lesions or other anatomical effects thatdisrupt or block electrical pathways through the targeted tissue. In thetreatment of cardiac arrhythmias, a specific area of cardiac tissuehaving aberrant electrical activity (e.g. focal trigger, slowconduction, excessively rapid repolarization, fractionated electrogram,etc.) is typically identified first before subsequent treatment. Thislocalization or identification can include obtaining monophasic actionpotential (“MAP”) electrograms of a particular cardiac region.Monophasic action potentials reproduce complete action potential ofcardiac tissues including the repolarization time course of myocardialcells with high accuracy and provide precise information on localactivation. MAP signals may be obtained by temporarily depolarizingselected tissue, with responsive electrical activity being recorded orotherwise monitored for an indication of aberrant electrical activity.After mapping and diagnosing aberrant tissue, a physician may decide totreat the patient by ablating the tissue.

Recording MAP signals and subsequently treating affected areas involvemaneuvering selected diagnostic and treatment devices through restrictedand sometimes tortuous pathways to access the desired tissue region. Therestrictive environment surrounding the targeted tissue can reduce theability of a device to be properly positioned to obtain the desiredinformation and/or deliver the treatment needed. To provide moreeffective and efficient medical treatments, it is thus desirable tooptimize the apparatus and method of use for the specific tissue to betreated, taking into account the characteristics of the tissue to bediagnosed and treated, as well as the location and pathway of access tothe selected tissue.

SUMMARY OF THE INVENTION

The present invention advantageously provides a medical device, system,and method for treating a patient by obtaining monophasic actionpotential (“MAP”) electrograms of cardiac tissue, either epicardially orendocardially, for the identification and treatment of electrical tissuedisorders. In particular, a medical device includes a shaft having adistal portion, a first monophasic action potential electrode arraycoupled to the distal portion, a second monophasic action potentialelectrode array coupled to a lateral surface of the shaft proximal tothe first array, and an additional electrode coupled to the shaft.

The second electrode array may be oriented substantially orthogonal tothe first electrode array, and may include a plurality of electrodespositioned along a length of the shaft, the electrodes arranged in tworows approximately 180 degrees apart from one another. The shaft may becontrollably deflectable within a defined plane, and the two rows ofelectrodes may be aligned in the plane. The first and second electrodearrays may include respective pluralities of substantially hemisphericalshaped electrodes, which may be made of substantially non-polarizablematerial. The first electrode array may include a plurality ofelectrodes, four for example, that are equally spaced from alongitudinal axis defined by the shaft. The additional electrode maydefine a substantially cylindrical band circumscribing the shaftproximally of the second electrode array, a substantiallysemi-cylindrical band circumscribing approximately half of acircumference of the shaft, or a dome at the distal portion of theshaft, with the first electrode array circularly arranged around thedome. The additional electrode may be recessed at the distal portion ofthe shaft, substantially centered with respect to the first electrodearray, and the device may also include a pacing electrode or electrodepair coupled to the shaft. The second electrode array may define atleast one port in fluid communication with a supply of electricallyconductive fluid. The medical device may also include a sheath coveringa portion of the second electrode array; the sheath having a sideaperture exposing another portion of the second electrode array. Thesecond electrode array may also be a retractable needle.

A medical device is also provided, including a catheter having a shaftwith a distal portion; a first plurality of substantially hemisphericalelectrodes coupled to the distal portion; a second plurality ofsubstantially hemispherical electrodes coupled to the shaft proximal ofthe first plurality, where the second plurality of electrodes areoriented substantially orthogonal to the first plurality of electrodes;and an additional electrode coupled to the shaft. The device may alsoinclude a console having a processor in electrical communication withthe first and second plurality of electrodes and the additionalelectrode, the processor programmed to obtaining a monophasic actionpotential recording from at least one of the first and second pluralityof electrodes. The additional electrode may be recessed at the distalportion of the shaft.

BRIEF DESCRIPTION OF THE DRAWINGS

A more complete understanding of the present invention, and theattendant advantages and features thereof, will be more readilyunderstood by reference to the following detailed description whenconsidered in conjunction with the accompanying drawings, wherein:

FIG. 1 is an illustration of an exemplary medical system constructed inaccordance with the principles of the present invention;

FIG. 2 is an illustration of an exemplary medical device constructed inaccordance with the principles of the present invention;

FIG. 3 is an illustration of another exemplary medical deviceconstructed in accordance with the principles of the present invention;

FIGS. 3A-3D are illustrations of additional exemplary medical devicesconstructed in accordance with the principles of the present invention;

FIG. 4 is an illustration of another exemplary medical deviceconstructed in accordance with the principles of the present invention;

FIG. 5 is an illustration of yet another exemplary medical deviceconstructed in accordance with the principles of the present invention;

FIG. 6 is a side view of the medical device of FIG. 5;

FIG. 7 is an illustration of an exemplary medical device constructed inaccordance with the principles of the present invention;

FIG. 8 is an illustration of another exemplary medical deviceconstructed in accordance with the principles of the present invention;

FIG. 9 is an illustration of an exemplary medical system constructed inaccordance with the principles of the present invention;

FIG. 10 is an illustration of a medical device constructed in accordancewith the principles of the present invention;

FIG. 11 is an illustration of another exemplary medical deviceconstructed in accordance with the principles of the present invention;

FIG. 12 is an illustration of exemplary deflection profiles of themedical device of FIG. 1;

FIG. 13 is an illustration of additional exemplary deflection profilesof the medical device of FIG. 1;

FIG. 14 is an illustration of an exemplary use of the medical device ofFIG. 1; and

FIGS. 15A-15C are illustrations of additional exemplary medical devicesconstructed in accordance with the principles of the present invention;

DETAILED DESCRIPTION OF THE INVENTION

The present invention provides medical devices, systems and methods forobtaining monophasic action potential electrograms for both endocardialand epicardial medical treatments. Referring now to the drawings inwhich like reference designators refer to like elements, there is shownin FIG. 1 an exemplary embodiment of a monophasic action potential(“MAP”) electrogram device system constructed in accordance with theprinciples of the present invention, designated generally as 10. Ofnote, the device components have been represented where appropriate byconventional symbols in the drawings, showing only those specificdetails that are pertinent to understanding the embodiments of thepresent invention so as not to obscure the disclosure with details thatwill be readily apparent to those of ordinary skill in the art havingthe benefit of the description herein. Moreover, while certainembodiments or figures described herein may illustrate features notexpressly indicated on other figures or embodiments, it is understoodthat the features and components of the system and devices disclosedherein may be included in a variety of different combinations orconfigurations without departing from the scope and spirit of theinvention.

As shown in FIG. 1, the medical system 10 generally includes a medicaldevice 12 coupled to a console 14 or other operating equipment. Themedical device 12 may be a catheter or surgical probe having diagnosticand/or treatment components positionable at or near a target tissueregion. For example, the medical device 12 illustrated in FIG. 1 mayinclude an elongate body or shaft 16 with proximal and distal portions.The shaft 16 may be both flexible and resilient, with sufficient columnstrength facilitating steady contact with tissue to improve signalfidelity in diagnosing contacted tissue as well as improve therapeuticthermal exchange between the device 12 and contacted tissue. The medicaldevice 12 may further include a handle 18 affixed to the proximalportion of the shaft 16.

The device 12 may further include a first treatment assembly 20 coupledto the distal portion of the shaft 16, as well as a second treatmentassembly 34 coupled to the shaft proximally of the first treatmentassembly 20. As shown in FIG. 1, the first treatment assembly 20 may beaffixed to the distal portion of the shaft 16, and may include a distaltip or dome housing 22 and a first array of electrodes (24 a, 24 b . . .collectively referred to as ‘24’) for measuring or detecting amonophasic action potential. The electrodes 24 may have a partiallyspherical recording surface with a relatively small outer diameter, suchas outer diameters of about one-half to two millimeters. In one examplethey may have a diameter of one millimeter. In the arrangement shown inFIG. 1, the electrodes 24 of the first array are each positioned anequal radial distance from a longitudinal axis 30 in different radialdirections. While the first array is illustrated as containing fourelectrodes, one or more electrodes in any suitable configuration may beimplemented. The electrodes may be made of one or more non-polarizingmaterials, such as silver, silver chloride, platinum, iridium, titaniumnitride, gold, stainless steel, aluminum, and alloys and combinationsthereof for example, to improve the fidelity of MAP electrograms.

The first array of electrodes 24 defines a distal recording geometry,which may have substantially radial symmetry around a longitudinal axis30 of the shaft 16. For example, an orthogonal array of the fourelectrodes of the first array 24 is shown, with each electrodepositioned at ninety degrees relative to the adjacent electrodes arounda circumference of the distal recording geometry. The dome housing 22may have a series of recesses or sockets 32 for receiving the electrodesin such a fixed spatial arrangement. Specifically in FIG. 1, there arefour sockets 32, each partially receiving one of the electrodes 24. Inthis arrangement, each recording electrode 24 protrudes from the domehousing 22 in the distal direction and a radial direction to enhance thelikelihood that at least one electrode of the array will achievesuitable contact with the tissue when the shaft 16 is advanced in thedistal direction toward the tissue selected for treatment. Thisarrangement with biaxial protrusion beyond the dome housing 22 alsoenhances the depolarizing effect of the first array of electrodes 24.

The dome housing 22 may be made of various materials, including polymersor metals. If the dome housing 22 is made of a polymer, such aspolyether-ether-ketone (PEEK), polysulfone, polyurethane, acetal, orother similar engineering plastic, it will have an electricallyinsulating effect to isolate the first electrode array 24. Alternately,the dome housing 22 may be made of an electrically conductive material,for example selected from the group consisting of silver, silverchloride, platinum, iridium, gold, stainless steel, aluminum, and alloysand combinations thereof. If the dome housing 22 is made of metal, aninsulating material such as one or more polymers may be provided betweenthe dome housing 22 and the electrodes 24, and the dome housing 22 mayfurther serve as a conduit for the delivery of radiofrequency ablationenergy.

The second treatment assembly 34 may include a second electrode array 26for measuring or detecting a monophasic action potential. The secondarray 26 may be constructed of similar materials and have similarfeatures to that of the first array of electrodes 24. The secondelectrode array 26 may be positioned proximally of the first electrodearray 24 and may also be positioned about a discrete portion of thecircumference of a lateral portion of the shaft 16 to provide anadditional and/or alternative site for monitoring or measuringelectrical activity of the tissue, e.g., to obtain a clearer MAP signalwith greater fidelity from epicardial tissue. For example, where thesurrounding tissue environment impedes adequate positioning of the firstelectrode array 24 in suitable contact with tissue to obtain ameasurement and/or deliver therapeutic energy, the second electrodearray 24 may be used to record or otherwise obtain the desiredinformation. In a particular example, the epicardium and the enclosedspaces afforded to medical devices accessing the epicardium areanatomically different than the endocardium. In an epicardial approach,there is often significant contact between portions of a device shaftwith the surrounding tissue. The position of the second electrode array26 on the shaft (as opposed to the distal portion or end location of thefirst electrode array 24) may be provided to facilitate positive contactwith selected epicardial tissue, while the distal end or tip position ofthe first electrode array 24 may be more suited for recordingendocardial activity within one or more chambers of the heart.

The medical device 12 may further include an additional electrode 28 onthe shaft 16 for determining a potential with relation to acorresponding potential obtained from the first electrode array 24and/or the second electrode array 26. The additional electrode 28 may bepositioned a pre-determined distance proximal of the first electrodearray 24, and another pre-determined distance proximal of the secondelectrode array 26. A dedicated pacing electrode 38 may also be includedfor synchronizing the MAP signals from the first and/or second electrodearrays to a local heartbeat. The additional electrode 28 and pacingelectrode 38 may have relatively smooth outer surfaces with minimal orno protrusion. The additional electrode 28 and pacing electrode 38 mayinclude substantially cylindrical bands surrounding or otherwiseattached to the shaft 16 coaxial with the longitudinal axis as depictedin FIG. 1. These electrodes may be flush with the outer surface of theshaft 16, or may be recessed to reduce a possibility of direct ordepolarizing contact with tissue. Alternatively, the additionalelectrode 28 may be recessed, while the pacing electrode 38 may belarger to increase its exposure and contact with tissue to be paced.

Each electrode of the first and second arrays, as well as the additionalelectrode 28 and pacing electrode 38 may have a substantially equivalentsurface area to optimize the electrical signals obtained from thevarious electrodes during their operation.

The medical device may also have a mechanism to indicate where at leastone component is currently positioned during the phases of a medicaltreatment. For example, the real-time location of the first electrodearray 24 and the second electrode array 26, as well as the additionalelectrode 28 and the pacing electrode 38 may be indicated with one ormore markers such as a radiopaque marker 110.

Referring now to FIG. 2, a distal portion of a medical device 46 isshown which includes one or more electrodes for ablation. For example, asecond treatment assembly may include four electrodes 48, additionalelectrodes 50 and 52 which may be used for recording MAP signals, pacingelectrical tissue activity, and/or delivering radiofrequency energy tothe contacted tissue. For example, after mapping aberrant tissue withthe electrodes 48, 50 and/or 52, the electrodes 50, 52 can also serve asradiofrequency (“RF”) ablation electrodes in a bipolar or unipolarmodality to ablate the selected tissue. Alternatively, electrodes 48 mayalso serve as RF ablation electrodes. The electrodes 50, 52 may have anysuitable shape or configuration. In the example of FIG. 2, they areshown as semi-cylindrical bands, limited to half the circumference ofthe catheter shaft, so as to focus RF energy more specifically to thetissue selected for treatment.

Now referring to FIG. 3, a distal portion of a medical device 54 isshown with a different example of a second treatment assembly, includingan alternating series of ring-shaped first electrodes 56 and secondelectrodes 58 coupled to a sidewall of a shaft 60. The first electrodes56 protrude from the shaft 60, and have a relatively small longitudinalsize or length to aid in temporarily depolarizing tissue. The additionof multiple second electrodes 58 along the shaft 60 allows multiplemeasurements to be taken along a length of the shaft (and thus thetissue in proximity to the shaft) without having to substantiallyreposition or move the device.

Referring to FIG. 3A, a distal portion of another medical device 112 isshown with an example of a second treatment assembly, having analternating series of ring-shaped first electrodes 114 and secondelectrodes 116 coupled to a shaft 118. In the example of FIG. 3A, thefirst electrodes 114 protrude radially from the shaft 118, and have arelatively small longitudinal size or length to aid in temporarilydepolarizing tissue. The first electrodes 114 may have a circumferentialor ring shape, with at least a first end affixed to the shaft 118 whilethe remainder of the first electrodes 114 are wrapped around the shaft118. Alternatively, different amounts of the first electrodes 114 may beaffixed to the shaft 118, such as for example just a first end and asecond end, the full length of first electrodes, or one or more portionsof first electrodes 114. Some or all of first electrodes 114 areelectrically conductive, for example an outer surface, a portionthereof, or the entirety of first electrodes 114. The second electrodes116 may have a cylindrical shape as shown in FIG. 3A or any othersuitable configuration. The addition of multiple second electrodes 116along the shaft 118 allows multiple measurements to be taken along alength of the shaft (and thus the tissue in proximity to the shaft)without having to substantially reposition or move the device.

To enhance the quality of monophasic action potential signals obtainedfrom the first electrodes 114 and the second electrodes 116, it may bedesirable to selectively add a conductive fluid or othersignal-enhancing agent in the local region of a treatment assembly. Forexample, the introduction of saline solution in the vicinity of thefirst electrodes 114 and the second electrodes 116 may improve thequality (such as amplitude, persistence, and fidelity) of the resultingsignals. Moreover, delivering fluid through the first electrodes 114during ablation will tend to cool them and lower their operatingtemperatures.

As shown in FIG. 3A, the first electrodes 114 may have a lumen with afirst end connecting to the shaft 118 and a lumen defined thereby, and asecond end opening in a delivery port 120. As a specific example, thefirst electrodes 114 may be formed of metal hypotube material.Accordingly, the physician may selectively administer thesignal-enhancing agent such as saline solution through the shaft lumen,through the lumen in the first electrodes 114, out the delivery ports120. In addition, saline evacuation ports may be incorporated into theshaft to evacuate excess saline from the field of the ablation. Thisevacuation prevents the saline from conducting ablation energy towardsextra-cardiac or other tissues. Evacuation of open flowing saline mayalso be accomplished through a delivery sheath. Alternatively, thesaline may flow through the first electrodes 114 and return throughanother catheter lumen which carries the fluid back out of the treatmentarea in a closed-loop manner. Open saline delivery to the pericardialspace may be avoided with a closed-loop configuration or arefrigerant-cooled system.

Referring to FIG. 3B, a distal portion of another medical device 122 isshown with another example of a second treatment assembly similar tothat shown in FIG. 3A, having an alternating series of ring-shaped firstelectrodes 124 and second electrodes 126 coupled to a shaft 128. In theexample of FIG. 3B, an effective portion of the first electrodes 124 maybe directed toward to a specific region of a patient's anatomy, such asfor example a selected portion of the surface of the shaft 128. Such anarrangement may enable a physician to limit collection of monophasicaction potential signals in a specific direction, and may deliver energyin that specific direction. For example, the desired direction forobtaining signals and/or delivering energy may be toward specific tissuesuch as the epicardium. This selected effective portion may be limitedto a small angular direction, or approximately half of the radialdirections or 180 degrees, or a majority of the circumference of theshaft 128. In addition, the effective portions of the first electrodes124 may all be arranged in the same radial direction, or in differentdirections such as a staggered arrangement, alternating directions, etc.The effective portions of the first electrodes 124 may be achieved invarious ways, including insulating some of each of the first electrodes124, or for example making the first electrodes 124 of an electricallyconductive material for the effective portions and a non-conductivematerial for other portions of the first electrodes 124. An example ofan electrically insulating material may be a polymer layer or coating,insulative potting, an insulating spray, etc. The first electrodes 124may also have a lumen for providing a conductive or signal-enhancingagent such as saline solution from a series of delivery ports 130.

Referring to FIG. 3C, a distal portion of another medical device 132 isshown with another example of a second treatment assembly similar tothat shown in FIG. 3B, having an alternating series of first electrodes134 and second electrodes 136 coupled to a shaft 138. In the example ofFIG. 3B, the first electrodes 134 extend around an angular portion ofthe shaft 138. Such an arrangement may also enable a physician to limitcollection of monophasic action potential signals in a specificdirection, for example toward to a specific region of a patient'sanatomy, and deliver energy in that specific direction. This selectedeffective portion may be limited to a small angular direction, orapproximately half of the radial directions or 180 degrees, or amajority of the circumference of the shaft 128. This arrangement of thefirst electrodes 134 extending partially around the shaft 138 definestheir effective portions without an insulating material as shown in theexample of FIG. 3D.

Referring to FIG. 3D, a distal portion of another medical device 142 isshown with another example of a second treatment assembly similar tothat shown in FIG. 3C, having an alternating series of first electrodes144 and second electrodes 146 coupled to a shaft 148, as well as asheath 150 with a side aperture or window. The sheath may thus cover aportion of the second electrodes 146, with the side window exposinganother portion of the second electrodes 146. In the example of FIG. 3D,the sheath 150 enables a physician to collect monophasic actionpotential signals, and also the deliver ablation energy, in a selecteddirection or directions. In addition, the sheath 150 can be rotatedslightly, for example to selectively treat a larger angular area.Moreover, the sheath 150 can be removed, so as to treat the full extentof the anatomy near the first electrodes 144 and the second electrodes146. The sheath 150 may also have a steering system, to enable selectivedeflection of one or more portions of the sheath 150 in variousdirections, and to advance the medical device 142 or otherwise treatselected anatomy.

Referring to FIG. 4, a distal portion of another medical device 62 isshown with another example of a second treatment assembly, having analternating first series of electrodes 64 and a second series ofelectrodes 66 coupled to a sidewall of a catheter shaft 68. The firstelectrodes 64 are not ring-shaped as shown in FIG. 3, but ratherprotrude from the catheter shaft 68 in discrete radial directionsapproximately 180 degrees apart from one another. The circumferentialseparation or alignment of the electrodes 64 may coincide with a planeof deflection or steering direction of the shaft. Alternately, a firstseries of electrodes may protrude from the catheter shaft 68 indifferent radial directions, for example 60 degrees apart from oneanother.

Referring to FIGS. 5 and 6, a distal portion of another medical device70 is shown, having four electrodes 72 received within a dome housing74, and a recessed electrode 76. Recessed electrode 76 is shown in ahemi-spherical recess in the distal surface of the dome housing 74,positioned on the longitudinal axis. This configuration can obtain a MAPsignal from one or more of the electrodes 72 with relation to therecessed electrode 76, when the distal tip of the medical device 70 isdirectly contacting a tissue site, such as within the epicardium of theheart.

Referring to FIG. 7, a distal portion of another medical device 78 isshown, having four recording electrodes 80 affixed to an insulator 82 ona dome housing 84. The dome housing may be constructed from anelectrically conductive material to function as both a referenceelectrode in recording action potentials in conjunction with therecording electrodes 80 as well as a conduit for radiofrequency ablationenergy. Referring to FIG. 8, another medical device 86 is shown, havinga unitary distal tip 88 which has four protrusions 90. The single-piecedistal tip 88 can be used to monitor, detect or otherwise measure MAPsignals, while reducing the number of components and associatedcomplexity with manufacturing and assembly of the device.

Referring to FIG. 9, a medical system 92 is shown in which anelectrode94 is alternatively positioned on the distal end of an outer sheath 96.A medical catheter 98 is slidably disposed through a lumen defined bythe sheath. Medical system 92 allows a physician to customize and adjustthe distance between the electrode 94 and the positions of a firsttreatment array of electrodes 100 and a second treatment array ofelectrodes 102.

FIG. 10 shows a medical device having a first electrode 104 and a secondelectrode 106. The first electrode 104 may have larger dimensions thanthe second electrode 106, allowing it to exert sufficient force againsta targeted tissue area to generate a depolarization while the proximal,recording electrode has a decreased contact force with the associatedtissue due to its reduced size. FIG. 11 shows a medical device having afirst electrode 104 and a second electrode which takes the form of aretractable needle electrode 108. The retractable needle electrode 108may protrude a short distance from the device shaft sufficient to causea depolarization of the contacted tissue while also causing very littledamage to the tissue.

As shown in FIGS. 1, 8, 9 and 14, each of the medical devices disclosedherein may include a handle 18 shaped for ease of use, and may have oneor more controls for manipulating one or more portions of the shafts,treatment assemblies, electrode arrays, or the like. Referring to FIG.1, for example, the handle 18 may have at least one steering control 40,which can be manipulated to cause bending at the line A-A. In particularfor access to epicardial tissue, a steering system of the catheter mayprovide bending either “into the page” or “out of the page” of FIG. 1,which may be described according to the illustrated orthogonal axes asbending of the distal tip along the Z axis. The steering system mayprovide progressive bending in one or more directions, to enable aphysician to steer the catheter system and direct the treatmentassemblies toward contact with the desired tissue for treatment. Anexample of a catheter with a steering system is shown in FIG. 12, whichdepicts a catheter bending around a distal curve. Also, the steeringsystem may have at least one additional axis or region of bending, forexample a proximal curve region as shown in FIG. 13. While the distaltreatment assembly is in the enclosed spaces of a minimally-invasiveprocedure, the practitioner can bend the catheter shaft in this way soit will tend to twist and orient the catheter shaft 16 such that eitherof the first and second treatment assemblies and their respectiveelectrode arrays will contact the selected tissue.

Specifically, a catheter steering system with a more proximal largecurve section as shown in FIG. 13 may be used to steer and direct thecatheter within the pericardial space. A catheter steering system with amore distal curve section as shown in FIG. 12 may be deflectable in adirection that is transverse to the plane of the more proximal steeringsection. This type of compound steering system enables general directionof the catheter with the proximal curve section, while allowingdeflection of the tip to deflect in a direction that may beperpendicular to the bending plane of the proximal curve section. Thedistal steering section may allow for a sharp curve with relativelysmall bending radius to improve contact with the epicardial surface,enhancing the monophasic action potential signals. In particular, thisdistal deflection may facilitate guiding the tip through layers ofepicardial fat that may be present, make positive contact with theepicardium and obtain monophasic action potential signals.

Additional possible features that may be provided on the handle includean actuation switch or configuration controls, a strain relief, and acoupling for the conduit connecting the catheter handle 18 to theconsole 14. The console 14 may have suitable components for obtainingsignals and potentials from the electrodes, and may also include one ormore sensors to monitor the operating parameters throughout the system,including for example, pressure, temperature, flow rates, volume, orsimilar measurements in the console or the medical device. The consolemay also have a radio-frequency (“RF”) generator 42 to generate RFablation energy and deliver it to an ablation electrode. The electricalpotential measured between the first or second electrode arrays and theadditional electrode 28 may be displayed or otherwise presented to thephysician on a display 44 for use in treating the patient. These signalsmay of course be displayed as desired, such as for example individually,in the aggregate as one representation, or one or more of the strongersignals may be presented.

Now referring to FIG. 14, an exemplary use of the medical system 10 isshown. In particular, the distal portion of the medical device 12 may bepositioned in proximity to or otherwise adjacent to a target tissueregion to be treated. The introduction and positioning of the medicaldevice 12 within the patient may include a percutaneous approach from asub-xyphoid incision or one or more small thoracotomy incisions to theepicardial surface of the heart, as shown in FIG. 12. Another accessmethod may use a needle advanced to the pericardium, guiding advancementof a dilator and sheath into the pericardial space, which provides for asmaller incision. The introduction and positioning of access tools canbe guided by use of visualization, imaging and dissection techniques,including, for example, fluoroscopy imaging in an intravascularprocedure and/or video thoracoscope in a minimally invasive surgicalprocedure.

Once the medical device 12 has been positioned in the vicinity of thetissue to be treated, the first or second electrode array may be placedin contact with the selected tissue region, which may include cardiactissue, for example. For example, the first electrode array 24 may beeasier to navigate and deflect into appropriate contact with a targetedtissue site within the relatively expansive interior chambers of theheart. Alternatively, the second electrode array 26 may be more suitablefor contacting a comparatively restrictive epicardial surface of theheart for diagnosis and treatment. The positioning of the medical device12 may include steering or deflecting at least a distal portion of thecatheter shaft 16. The medical device can be manipulated to apply localpressure from at least one electrode of the respective arrays to thetissue, causing local depolarization to obtain at least one monophasicaction potential signal. In particular, steering control 40 may beactuated to cause bending of the catheter shaft 16 in a selecteddirection at one or more positions. For example, steering control maycause bending of the catheter shaft 16 at line A-A along the Z axis, toorient either the distally-oriented first electrode array 24 or thelaterally-oriented second electrode array 26 to contact the desiredtissue.

The steering control may also enable bending of the catheter shaft 16 ina distal curve and a proximal curve, as shown in FIGS. 12 and 13respectively. The features of the medical systems and devices accordingto the present invention provide multiple electrode arrays to facilitateenhanced contact with restrictive tissue areas with a single device tothus improve signal fidelity and treatment efficacy. When an acceptableMAP signal is obtained from at least one recording electrode or counterelectrode with reference to a reference electrode, the physician candiagnose and treat the patient accordingly. Such treatment may involvedelivering RF energy from a generator to an ablation electrode.

Now referring to FIGS. 15A-C, a distal portion of a medical device 152is shown with a different example of a treatment assembly, including aloop or ring 154 with an alternating series of first electrodes 156 andsecond electrodes 158. The first electrodes 156 protrude from theresilient ring 154, and may have a relatively small rounded size aid intemporarily depolarizing tissue. The second electrodes 158 are alsoaffixed to the ring 154 and may be interspersed among the firstelectrodes 156 to obtain monophasic action potential signals, allowingmultiple measurements to be taken along the path of the ring 154 withouthaving to substantially reposition or move the device. Of course, thetreatment assembly may have any suitable shape, including circular,oval, polygonal, or irregular. The shape of the treatment assembly mayalso be selected to correspond with specific anatomy.

The treatment assembly may be made of any suitable materials having thedesired characteristics, for example biocompatible, shapeable, elastic,or resilient. The shape of the treatment assembly may be adjusted duringtreatment with various shaping elements, which enables transformation ofthe treatment assembly from a deployment shape such as shown in FIG. 15Ato a variety of treatment shapes as shown for example in FIG. 15B andFIG. 15C. Accordingly, an adjustable treatment array enables mapping andablation of a customizable treatment area of various shapes and sizes,depending on how much the array is expanded or manipulated. Also, thetreatment array may be pre-shaped in many configurations and sizes forspecific targeted anatomical sites. An example shaping element isillustrated as an actuator 160 affixed to the ring 154. The actuator 160can be extended or retracted to configure the treatment assembly andcontract or expand the ring 154.

In another example, the medical device may have electrodes arranged onlyon one side of the treatment array, to more specifically contact, mapand treat selected tissues, such as for example the epicardial surfaceof the heart. During ablation, it may be desirable to cool theelectrodes using for example closed loop or open loop flow of saline orinternal refrigerant.

It will be appreciated by persons skilled in the art that the presentinvention is not limited to what has been particularly shown anddescribed herein above. Of note, while certain components, such as thevarious electrodes or other items disclosed herein, are indicated asmapping, reference, and/or recording electrodes, it is understood theseare exemplary functions that do not limit additional uses of thedesignated electrodes or components for alternative functions. Inaddition, unless mention was made above to the contrary, it should benoted that all of the accompanying drawings are not to scale. A varietyof modifications and variations are possible in light of the aboveteachings without departing from the scope and spirit of the invention,which is limited only by the following claims.

What is claimed is:
 1. A medical device, comprising: a shaft having adistal portion; a first electrode array coupled to the distal portion; asecond electrode array coupled to a lateral surface of the shaftproximal to the first array, the second electrode array being orientedsubstantially orthogonal to the first electrode array; and an additionalelectrode coupled to the shaft.
 2. The medical device according to claim1, wherein the second electrode array includes a plurality of electrodespositioned along a length of the shaft, the electrodes arranged in tworows approximately 180 degrees apart from one another.
 3. The medicaldevice according to claim 2, wherein the shaft is controllablydeflectable within a defined plane, and the two rows of electrodes arealigned in the plane.
 4. The medical device according to claim 1,wherein at least one of the first electrode array and the secondelectrode array includes a plurality of substantially hemisphericalshaped electrodes.
 5. The medical device according to claim 1, whereinthe first electrode array includes a plurality of electrodes made ofsubstantially non-polarizable material.
 6. The medical device accordingto claim 1, wherein the first electrode array includes four electrodesequally spaced from a longitudinal axis defined by the shaft.
 7. Themedical device according to claim 1, wherein the additional electrodedefines a substantially cylindrical band circumscribing the shaftproximally of the second electrode array.
 8. The medical deviceaccording to claim 1, wherein the additional electrode defines asubstantially semi-cylindrical band circumscribing approximately half ofa circumference of the shaft.
 9. The medical device according to claim1, wherein the additional electrode includes a dome at the distalportion of the shaft.
 10. The medical device according to claim 9,wherein the first electrode array is circularly arranged around thedome.
 11. The medical device according to claim 1, wherein theadditional electrode is recessed at the distal portion of the shaft. 12.The medical device according to claim 11, wherein the additionalelectrode is substantially centered with respect to the first electrodearray.
 13. The medical device according to claim 1, further comprising apacing electrode coupled to the shaft.
 14. The medical device accordingto claim 1, wherein the second electrode array defines at least one portin fluid communication with a supply of electrically conductive fluid.15. The medical device according to claim 1, further comprising a sheathhaving a side aperture; the sheath covering a first portion of thesecond electrode array, and the side aperture exposing a second portionof the second electrode array.
 16. The medical device according to claim1, wherein the second electrode array is a retractable needle.
 17. Amedical device, comprising: a catheter having a shaft with a distalportion; a first plurality of substantially hemispherical electrodescoupled to the distal portion; a second plurality of substantiallyhemispherical electrodes coupled to the shaft proximal of the firstplurality, wherein the second plurality of electrodes are orientedsubstantially orthogonal to the first plurality of electrodes; and anadditional electrode coupled to and recessed within a distal portion ofthe shaft.
 18. The medical device according to claim 17, furthercomprising a console having a processor in electrical communication withthe first and second plurality of electrodes and the additionalelectrode, the processor programmed to obtain a monophasic actionpotential recording from at least one of the first and second pluralityof electrodes.